BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3081787 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05447
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 9, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION REVEALED THAT THE DISPLAY LENS WAS PEELING OFF FROM THE PUMP. INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. A NEW DISPLAY SCREEN WAS INSERTED AND THE DISPLAY ILLUMINATED TO NORMAL CONTRAST. UNRELATED TO THE COMPLAINT, THERE WAS AN EVIDENCE OF INTERNAL MOISTURE NOTED INSIDE THE PUMP.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING PIXEL COLOR CHANGE OF THE DISPLAY SCREEN. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED DISPLAY SCREEN DEFECT REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184019 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1